Leaving EMA

The European Medicines Agency (EMA) has begun to migrate to Amsterdam. The relationship the UK will have with EMA is up in the air, but already the changes are having an effect on the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) work. They are beginning to fail to win new contracts for and lose exiting ones:

The MHRA won just two contracts this year and the EMA said that that work was now off limits. “We couldn’t even allocate the work now for new drugs because the expert has to be available throughout the evaluation period and sometimes that can take a year,” said a spokeswoman.

In a devastating second blow, existing contracts with the MHRA are also being reallocated to bloc members.

It’s not just a blow for the MHRA, but also for the EU, who will be losing British expertise in pharmacovigilance. In the world of drug regulation, there are clear public health advantages to some harmonisation and shared work due to scale and pooling effects. As I said just prior to the Brexit vote in 2016:

“Even if one accepted that the MHRA would adjust relatively quickly compared to EMA, the damage to harmonisation, and pooled resources for drug safety, would be a net loss for the UK.”

That’s not to say that even within the existing EMA there aren’t some drug safety variability problems, but a failure of the UK to be a part of, or contribute to, EMA is bad news for both the UK and the EU medicine users.